Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT02413580 | A Study to Assess the Efficacy and Safety of IGIV-C in Patients With Myasthenia Gravis Exacerbations | PHASE3 | COMPLETED | 49 | — | — | Mar 1, 2015 | Apr 1, 2018 | Apr 24, 2020 | 31 | Argentina, Belgium +10 |
Mean Change in Quantitative Myasthenia Gravis (QMG) Scale Score from Baseline (Day 0) to Day 14. The minimum and maximum scores of the QMG Scale are 0 and 39, respectively, and a higher score means a worse outcome.
| Arm | Type | Description |
|---|---|---|
| IGIV-C Treatment | EXPERIMENTAL | In this arm, subjects with myasthenia gravis exacerbations were treated with an IV dose of 2 g/kg of IGIV-C, which was administered over 2 consecutive days at a dose of 1 g/kg per day. |
| Name | Type | Description |
|---|---|---|
| IGIV-C | BIOLOGICAL | An IV dose of 2 g/kg of IGIV-C was administered over 2 consecutive days at a dose of 1 g/kg per day. |
Inclusion Criteria: * Was male or female aged ≥18 years. * Subjects must be willing and able to provide written informed consent (if applicable, a legally authorized representative may provide informed consent on behalf of the subject). * Subjects who met the clinical criteria for diagnosis of MG w...